A matter of life and death? the Heart Protection Study and protection of clinical trial participants

Controlled Clinical Trials

Volumn 24, Issue 5, 2003, Pages 501-505

  Migrino, Raymond Q ^a   Topol, Eric J ^a  

^a LERNER RESEARCH INSTITUTE   (United States)

Author keywords

Clinical trials; Data and safety monitoring board; Simvastatin; Stopping rules

Indexed keywords

ESTROGEN; MEDROXYPROGESTERONE; SIMVASTATIN; ZIDOVUDINE;

ARTICLE; BREAST CANCER; CANCER RISK; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; HEART DISEASE; HEART PROTECTION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFORMATION PROCESSING; LUNG EMBOLISM; MEDICAL RESEARCH; METHODOLOGY; PATIENT MONITORING; POSTMENOPAUSE; PROFESSIONAL STANDARD; PROTECTION; RESEARCH SUBJECT; RISK BENEFIT ANALYSIS; SAFETY; STROKE; TREATMENT OUTCOME; CONTROLLED CLINICAL TRIAL; CORONARY ARTERY DISEASE; FOLLOW UP; MORTALITY; REVIEW; SURVIVAL;

CONTROLLED CLINICAL TRIALS; CORONARY DISEASE; FOLLOW-UP STUDIES; HUMANS; RESEARCH DESIGN; SIMVASTATIN; SURVIVAL ANALYSIS;

EID: 1542757334     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(03)00091-6     Document Type: Article

References (9)

1. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 360:2002;7-22.
2. MRC/BHF Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol-lowering therapy and of antioxidant vitamin supplementation in a wide range of patients at increased risk of coronary heart disease death: early safety and efficacy experience. Eur Heart J. 20:1999;725-741.
3. Geller N.L. Planned interim analysis and its role in cancer clinical trials. J Clin Oncol. 5:1987;1485-1490.
4. Green S.J., Fleming T.R., O'Fallon J.R. Policies for study monitoring and interim reporting of results. J Clin Oncol. 5:1987;1477-1484.
5. Lilford R.J., Braunholtz D., Edwards S., et al. Monitoring clinical trials - interim data should be publicly available. BMJ. 323:2001;441-442.
6. Rossouw J.E., Anderson G.L., Prentice R.L., et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 288:2002;321-333.
7. O'Brien P.C., Fleming T.R. A multiple testing procedure for clinical trials. Biometrics. 35:1979;549-556.
8. Simberkoff M.S., Hartigan P.M., Hamilton J.D., et al. Ethical dilemmas in continuing a zidovudine trial after early termination of similar trials. Control Clin Trials. 14:1993;6-18.
9. Bird S.M. Monitoring clinical trials. Dissemination of decisions on interim analyses needs wider debate. BMJ. 323:2001;1424.